FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Anatomic Total Shoulder Indications:
The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity;
· Rotator cuff tear arthropathy;
· Humeral fracture.
· Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The AltiVate Reverse Humeral Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
· Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/ or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity.
The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.

Device Description

The AltiVate Reverse® Humeral Shoulder Stem is a single component manufactured from wrought forged titanium alloy. The stem distal body is cylindrical with four flutes. The stem's body flares proximally to a trapezoidal cross-sectional midbody, and a hemispherical shell is most superior. The stem has porous coating applied on, and around, the outer spherical diameter of the shell. Porous coating is applied, under the shell, to the stem's medial, anterior, and posterior surfaces. Two fins are located in symmetry on the stem's antero-lateral and mediolateral midbody corners to promote shoulder humeral fracture tuberosity reduction to providing rotational stability. The fins protrude at 45° from the frontal plane. Each fin has two suture holes for reattachment of soft tissue or bone fragments in cases of proximal humeral fracture. A larger hole is located under the stem's shell which traverses the stem body through the medial-lateral plane to allow through a cerclage wire or suture anchorage point. Four suture holes are located through the stem's shell to aid in soft tissue reattachment and fractured shoulder tuberosity reduction. A larger hole spans the stem's midbody within the medial-lateral plane. The hole is tapered to maintain constant stem wall thickness without compromising fatigue strength. This hole can be used for temporary or long-term bone graft fixation in addition to soft-tissue reattachment. Three slots are located through the stem's shell: anterior, posterior, and medial. These slots allow surgical access by osteotome, or other instruments, for stem removal and separation from bone during revision surgery. A central screw thread within the stem's shell allows mating interface with other surgical instruments or implants.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device (AltiVate Reverse Humeral Stem, 48mm). It is not a study that proves the device meets acceptance criteria.

The 510(k) process is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. It typically relies on showing substantial equivalence through non-clinical testing, engineering rationale, and comparison to predicate devices, rather than a clinical study with acceptance criteria and statistical proof of performance.

Therefore, many of the questions regarding acceptance criteria, study design, sample sizes, expert ground truth, and human reader performance simply do not apply to this type of regulatory submission. The information provided in the document focuses on:

Indications for Use: What the device is intended for.
Device Description: What the device is made of and how it's designed.
Predicate Devices: Previously cleared devices to which the subject device is compared.
Non-Clinical Testing/Engineering Rationale: How the substantial equivalence was demonstrated (e.g., mechanical testing previously done for predicate devices, porous coating evaluation, dimensional comparisons).
No Clinical Testing: A key point from the document is explicitly stating "Clinical testing was not required."

Based on the provided document, I cannot answer the questions as a study proving device performance against acceptance criteria was not conducted or submitted for this 510(k) clearance.

However, I can extract the relevant information that is present in the document.

Summary of what can be gleaned from the document (and what cannot):

This document is a 510(k) clearance letter from the FDA for a new version of a previously cleared shoulder implant. The primary purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove efficacy or safety through a clinical study with pre-defined acceptance criteria in the way an AI/ML device often would.

Therefore, most of the questions about acceptance criteria, study design, expert review, and ground truth for performance evaluation are not applicable to the content of this document. This clearance was based on non-clinical testing and engineering rationale, demonstrating that the new device is comparable to existing predicate devices.

Here's what can be inferred or explicitly stated from the document:

1. A table of acceptance criteria and the reported device performance:
- Not applicable in the context of this 510(k) submission. The document does not describe performance acceptance criteria for a clinical study or a table of performance metrics. The "acceptance criteria" here is met by successfully demonstrating substantial equivalence through non-clinical means.
- The document states: "All evaluations determined that the device is substantially equivalent to the predicate devices." This is the ultimate "performance" metric for a 510(k).
2. Sample sizes used for the test set and the data provenance:
- Not applicable. No clinical test set data or human subject data is mentioned. The testing was non-clinical (mechanical, dimensional, porous coating analysis).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth established by experts for a test set is mentioned.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a shoulder implant, not an AI/ML diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the way this question is usually posed for AI/ML or diagnostic devices. The "ground truth" for this 510(k) was based on the performance and safety profiles of the predicate devices and engineering evidence that the new device is dimensionally, materially, and functionally equivalent in its intended use.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is mentioned.

What is stated in the document regarding testing:

Non-Clinical Testing: "Mechanical testing was previously completed and submitted with K141990 and K172351. Evaluations of this testing as compared to the subject device determined that the previous testing could be applied to the subject device. Testing included porous coating surface area evaluation and dimensional comparisons."
Engineering Rationale: "No mechanical testing was performed on the subject device humeral stems and that engineering rationale was used to compare the subject device humeral stems to the predicate devices K172351, K162024, and K122698."
Endotoxin Assessment: "DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing."
Clinical Testing: "Clinical testing was not required."

In essence, this document shows the regulatory clearance for a traditional medical device based on equivalence to existing devices, not a study evaluating an AI/ML system or a new clinical claim with specific performance metrics.

Summary

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”